Nutrition, HealthyNCT05687812
Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.
A study testing Cephalaria Syriaca flour-added bread in people with Nutrition, Healthy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Cephalaria Syriaca is a common weed in Anatolia and grows wild in wheat fields, with high fat, protein, and dietary fiber content. This study it is aimed to evaluate the effects of lowering the glycemic index of white bread consumed in large quantities in Turkey by adding Cephalaria Syriaca, on healthy, obese, and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Cephalaria Syriaca flour-added bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy group (n=20):
- 18-65 years of age, non-obese and non-diabetic healthy individuals
- OGTT is normal
- Body Mass Index (BMI)= 18.5-24.9 kg/m2
- Diabetic group (n=20):
- Individuals aged between 18-65 years with Type 2 Diabetes
Show all 11Show fewer
- Using only metformin
- BMI= 18.5-29.9 kg/m2
- Obese group (n=20):
- 18-65 years of age, non-diabetic and obese individuals;
- BMI ≥ 30 kg/m2
Who cannot join
- Individuals with
- Smoking
- Use Alcohol
- Pregnant
- Breastfeeding
- Those with chronic diseases (CKD, COPD, Malignancy,..)
Show all 9Show fewer
- Using food supplements
- Using DPP-4 inhibitors and GLP-1release analog in the treatment of DM
- Professional athlete or excessive physical activity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism
Istanbul, Capa, 34093
About this study
Cephalaria Syriaca is a common weed in Anatolia and grows wild in wheat fields, with high fat, protein, and dietary fiber content. This study it is aimed to evaluate the effects of lowering the glycemic index of white bread consumed in large quantities in Turkey by adding Cephalaria Syriaca, on healthy, obese, and diabetic individuals.
Read the detailed description
Nutrition is essential in the treatment and management of diabetes and obesity, and other accompanying diseases. Consumption of low glycemic index (GI) foods is the primary approach in medical nutrition therapy to ensure glycemic control and long-term satiety. The glycemic index is the rate at which foods raise blood sugar. The GI is determined by comparing the area of increase in blood glucose within 2 hours after consumption and absorption of a test food containing 100 g of digestible carbohydrates to the area of increase in glucose generated by the reference food containing the same amount of carbohydrates (primarily white bread). The GI value of the food taken as a reference is 100, and the reference ranges of foods are ≤55 low, 56-69 moderate, and ≥70 high GI. Annual bread consumption is much higher than the world average in Turkey and is about 400 g/day. It has been determined that 66% of the energy consumed per capita is provided from cereals, 56% of this energy is met from bread, and 50% of the protein in the daily diet is completed from bread.
It has been reported that the GI of white bread is 87 in our country and 70 in other countries. Reducing the GI value of a large amount of food consumed will be a positive step for obesity and diabetes management.
Cephalaria syriaca, common in Anatolia and growing wild in wheat fields, has high oil (~20%), protein (15.5%), dietary fiber (25.5%), and polyphenol content and is an annual weed rich in vitamins and minerals. It is known that the flour obtained from Cephalaria Syricia seed strengthens even the flours with low core quality. For this reason, it is used especially in rural areas to increase dough and bread quality. It is known that dietary fiber, fat, and protein contents in foods lower the GI value. Therefore, Cephalaria Syricia flour added to bread flour is expected to reduce the GI value of bread. A study conducted in 2020 showed that the GI value of regular white bread with 5% Cephalaria Syricia flour added decreased by 17%. Although there are in-vitro studies on the effects of Cephalaria Syricia in the literature, no clinical studies with published results have been found. From this point of view, this study is planned to investigate the effects of 0.2% Cephalaria Syricia flour added to bread (market name: İstanbul Halk Ekmek, Akdeniz Bread) on blood glucose and related hormones levels of individuals with diabetes and obesity and healthy volunteers.
- Conditions
- Nutrition, Healthy
- Being tested
- Cephalaria Syriaca flour-added bread
- Keywords
- Cephalaria Syriaca, glycemic index, type 2 diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalaria Syriaca flour-added breadDietary supplement
100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH).
| Study group | Role | What they receive |
|---|---|---|
| Diabetic group | Experimental | After 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes. Receives: Dietary Supplement: Cephalaria Syriaca flour-added bread |
| Non-diabetic obese group | Experimental | After 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes. Receives: Dietary Supplement: Cephalaria Syriaca flour-added bread |
| Non-diabetic and non-obese healthy group | Experimental | After 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes. Receives: Dietary Supplement: Cephalaria Syriaca flour-added bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma GLP-1 levels changes
Change in baseline GLP-1 levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma PYY levels changes
Change in baseline PYY levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma Leptin levels changes
Change in baseline Leptin levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma Ghrelin levels changes
Change in baseline Ghrelin levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma IL-6 levels changes
Change in baseline IL-6 levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma insulin levels changes
Change in baseline insulin levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma glucose levels changes
Change in baseline glucose levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Plasma c-peptide levels changes
Change in baseline c-peptide levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Secondary outcomes (2)
Plasma triglyceride levels changes
Change in baseline triglyceride levels at 2 hours. Measured by plasma samples.
Measured: Through OGTT test completion, an average of 2 hours
Appetite regulation
Change in baseline appetite at 2 hours. Subjective appetite assessed with visual analog scales.
The visual analog scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement tool for subjective characteristics or attitudes that cannot be measured directly.
Visual analogue scales (VAS) were used to measure hunger (H), fullness (F), desire to eat (DtE), and prospective food consumption (PFC) scores (-s) immediately before consump- tion of test meal and at 60, 120, and 180 min later. The VAS-s were 100-mm straight line, and the patients were asked to make a vertical mark across this line corresponding to their concurrent feelings from 0 (not at all) to 100 (very) H, F, DtE, and PFC.
Measured: Through OGTT test completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Calikoglu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687812
- Sponsor's protocol ID
- 2022/342
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cephalaria Syriaca Flour-added Bread on Glucose Metabolism and Appetite Parameters in Individuals With Obesity, Diabetes, and Healthy Controls.
- ClinicalTrials.gov ID
- NCT05687812
- Acronym / sponsor ID
- 2022/342
- Conditions
- Nutrition, Healthy
- Keywords
- Cephalaria Syriaca, glycemic index, type 2 diabetes, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cephalaria Syriaca is a common weed in Anatolia and grows wild in wheat fields, with high fat, protein, and dietary fiber content. This study it is aimed to evaluate the effects of lowering the glycemic index of white bread consumed in large quantities in Turkey by adding Cephalaria Syriaca, on healthy, obese, and diabetic individuals.
Detailed description
Nutrition is essential in the treatment and management of diabetes and obesity, and other accompanying diseases. Consumption of low glycemic index (GI) foods is the primary approach in medical nutrition therapy to ensure glycemic control and long-term satiety. The glycemic index is the rate at which foods raise blood sugar. The GI is determined by comparing the area of increase in blood glucose within 2 hours after consumption and absorption of a test food containing 100 g of digestible carbohydrates to the area of increase in glucose generated by the reference food containing the same amount of carbohydrates (primarily white bread). The GI value of the food taken as a reference is 100, and the reference ranges of foods are ≤55 low, 56-69 moderate, and ≥70 high GI. Annual bread consumption is much higher than the world average in Turkey and is about 400 g/day. It has been determined that 66% of the energy consumed per capita is provided from cereals, 56% of this energy is met from bread, and 50% of the protein in the daily diet is completed from bread.
It has been reported that the GI of white bread is 87 in our country and 70 in other countries. Reducing the GI value of a large amount of food consumed will be a positive step for obesity and diabetes management.
Cephalaria syriaca, common in Anatolia and growing wild in wheat fields, has high oil (~20%), protein (15.5%), dietary fiber (25.5%), and polyphenol content and is an annual weed rich in vitamins and minerals. It is known that the flour obtained from Cephalaria Syricia seed strengthens even the flours with low core quality. For this reason, it is used especially in rural areas to increase dough and bread quality. It is known that dietary fiber, fat, and protein contents in foods lower the GI value. Therefore, Cephalaria Syricia flour added to bread flour is expected to reduce the GI value of bread. A study conducted in 2020 showed that the GI value of regular white bread with 5% Cephalaria Syricia flour added decreased by 17%. Although there are in-vitro studies on the effects of Cephalaria Syricia in the literature, no clinical studies with published results have been found. From this point of view, this study is planned to investigate the effects of 0.2% Cephalaria Syricia flour added to bread (market name: İstanbul Halk Ekmek, Akdeniz Bread) on blood glucose and related hormones levels of individuals with diabetes and obesity and healthy volunteers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic group | Experimental | Dietary Supplement: Cephalaria Syriaca flour-added breadAfter 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes. |
| Non-diabetic obese group | Experimental | Dietary Supplement: Cephalaria Syriaca flour-added breadAfter 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes. |
| Non-diabetic and non-obese healthy group | Experimental | Dietary Supplement: Cephalaria Syriaca flour-added breadAfter 10-12 h fasting, an OGTT test with 75 g glucose was performed on the participants, showing no glucose metabolism disorder. Another independent day was chosen as the test day, and the participants were asked to no-restrict carbohydrates and not make any changes in their diet in the days before the test. Volunteers were fed 100g of white bread containing only 250 ml of water and 50g of carbohydrate (CH) for breakfast (after 12 hours of fasting). After 1 week, the same participants were fed 250 ml of water and 100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). During the test, venous and capillary blood samples were taken at 0, 30, 60, 90, and 120 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-65 years of age, non-obese and non-diabetic healthy individuals
- OGTT is normal
- Body Mass Index (BMI)= 18.5-24.9 kg/m2
- Individuals aged between 18-65 years with Type 2 Diabetes
- Using only metformin
Key exclusion criteria (9 listed)
- Individuals with
- Smoking
- Use Alcohol
- Pregnant
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cephalaria Syriaca flour-added bread100g of test bread (consisting of 0.2% Cephalaria Syriaca flour bread) containing 50g of carbohydrates (KH). | Dietary supplement | Diabetic group, Non-diabetic and non-obese healthy group, Non-diabetic obese group |
Primary outcome
Plasma GLP-1 levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline GLP-1 levels at 2 hours. Measured by plasma samples.
Plasma PYY levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline PYY levels at 2 hours. Measured by plasma samples.
Plasma Leptin levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline Leptin levels at 2 hours. Measured by plasma samples.
Plasma Ghrelin levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline Ghrelin levels at 2 hours. Measured by plasma samples.
Plasma IL-6 levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline IL-6 levels at 2 hours. Measured by plasma samples.
Plasma insulin levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline insulin levels at 2 hours. Measured by plasma samples.
Plasma glucose levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline glucose levels at 2 hours. Measured by plasma samples.
Plasma c-peptide levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Change in baseline c-peptide levels at 2 hours. Measured by plasma samples.
2 secondary outcomes
Plasma triglyceride levels changes
Time frame: Through OGTT test completion, an average of 2 hours
Appetite regulation
Time frame: Through OGTT test completion, an average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cephalaria Syriaca flour-added bread in people with Nutrition, Healthy, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma GLP-1 levels changes (time frame: Through OGTT test completion, an average of 2 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.